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Consortium sifting through MS data to find new endpoint

A consortium is targeting the discovery of a new primary endpoint for multiple sclerosis trials by analyzing data from current studies. The alliance hopes that by sifting through the wealth of data generated by MS trials, they can find a clinician-reported outcome measure of disability.

Discovery of a new primary endpoint could kick-start research into progressive forms of MS. In these cases, symptoms get gradually worse--instead of suddenly appearing as attacks--and this makes it hard to detect changes. By standardizing and analyzing trial data, the National Multiple Sclerosis Society and FDA-backed Critical Path Institute (C-Path) aim to find an outcome that overcomes this limitation.

The National MS Society plans to bring together industry, academia, patient representatives and regulators to work on the problem, but details of the companies involved are yet to emerge. Yet, it is clear that the initiative has high-level backing. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), has already spoken in support of the initiative, saying it will "facilitate a combination of available data and expertise to generate the best possible drug development tool."

Once up and running, the Multiple Sclerosis Outcome Assessments Consortium (MSOAC) will pull together data from a range of MS trials. The plan fits with the collaboration trend--epitomized by Big Pharma consortium TransCelerate--that has risen alongside acceptance that some drug development problems are too big for any one company. Without data from a large number of MS trials--and the computing power to analyze the information--MSOAC would struggle to find a new endpoint.

These sorts of alliances were at the heart of the formation of C-Path in 2005. Since then C-Path has created collaborations involving 41 pharma companies. "C-Path consortia are 'action tanks' that tackle what no one organization can take on solo," its CEO Carolyn Compton said.